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Novartis, launching COVID-19 trial, seeks to prove hydroxychloroquine's worth

Novartis will soon start a clinical study designed to deliver definitive proof as to whether hydroxychloroquine, a decades-old malaria pill, can benefit patients with COVID-19.

The trial, which will enroll about 450 patients, joins a host of other studies that are putting to the test early enthusiasm for the drug's potential. Initial data on hydroxychloroquine's effectiveness has conflicted, setting the drug's proponents — most prominently President Donald Trump — against health officials and experts who've urged for further study.

Patients enrolled into the Novartis-sponsored study will be randomized to one of three groups, receiving either placebo, hydroxychloroquine or a combination of hydroxychloroquine with the commonly used antibiotic azithromycin.

In mid-March, a group of physicians in the south of France reported early results from a small study of COVID-19 patients treated with hydroxychloroquine and azithromycin.

The data, which were published online without peer review, showed what appeared to be striking reductions of the viral levels in patients' bodies. Soon after, President Trump touted the drug's potential, describing at a press briefing on March 19 "very, very encouraging early results."

The Marseilles trial, however, had many flaws, chief among them its small size and lack of a randomized control group. While the researchers have since updated their findings with data from additional patients, other preliminary studies have shown more mixed results or highlighted the potential harms of using hydroxychloroquine or its various chemical cousins. Clinical tests of the drugs to date have been small and have typically lacked measures, such as randomization or blinding, that are designed to eliminate bias and reduce the chance of misleading results.

A number of studies, Novartis' planned trial now among them, aim to more rigorously test early hypotheses about which existing drugs might help. Several large ones examining hydroxychloroquine are already underway in the U.S., the U.K. and France.

Author: Ned Pagliarulo

Published: April 20, 2020

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